Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217324

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BACLOFEN (BACLOFEN)
0.5MG/ML
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: BACLOFEN
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 0.5MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217324
Product Number: 001
Approval Date: Feb 22, 2023
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

BACLOFEN (BACLOFEN)
1MG/ML
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: BACLOFEN
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 1MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217324
Product Number: 002
Approval Date: Feb 22, 2023
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

BACLOFEN (BACLOFEN)
2MG/ML
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: BACLOFEN
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 2MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217324
Product Number: 003
Approval Date: Feb 22, 2023
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information